New heart valve device aims to fix tricuspid leak without open surgery

NCT ID NCT07691307

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial tests a new device called the TruGamma system, which replaces the tricuspid valve without open surgery. It is for people aged 65 and older with severe tricuspid regurgitation who are not candidates for surgery. The study compares the device plus standard medication to medication alone, measuring improvements in heart function, symptoms, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
TruGamma transcatheter tricuspid valve replacement system
What this could lead to
If successful, this device could offer a less invasive treatment option for people with severe tricuspid regurgitation who cannot undergo surgery, potentially improving heart function and daily life.
What could go wrong
This is a pivotal trial, but the device is still investigational. Risks include procedural complications, device failure, or no significant benefit over standard medical therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100037, China

    Contact Phone: •••-•••-•••• Email: •••••@•••••

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